Study S000585

A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03684642
Acronym: AMPLITUDE-D
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: TERMINATED
Enrollment: 908
Start: 2018-09-26
Primary completion: 2020-10-13
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Efpeglenatide; DRUG:Dulaglutide; DRUG:Background therapy Metformin
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: EUDRACT_NUMBER:2017-002956-10; OTHER:U1111-1205-3150; NIH:2017

Registered primary outcomes

Change From Baseline to Week 56 in HbA1c [Baseline to Week 56]

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